Adult Bladder and Quality of Life Evaluation in Spina Bifida (ABLE-SB)

Patient Reported Outcomes for Bladder Management Strategies in Young Adults With Spina Bifida

Spina bifida (SB) is a birth defect that affects the spine, often causing paralysis in the legs and problems with bladder and bowel control. Managing these bladder issues is important, but different methods, like using a catheter or surgery, can impact a person's quality of life. This study looks at how different bladder management methods affect the quality of life for young people with SB. Researchers will ask people with SB to complete a survey about how they manage their bladder and how it impacts their daily lives. The main goal is to find out if certain bladder management methods are associated with a better quality of life. This information could help doctors make better treatment decisions and counsel young people living with SB.

Study Overview

• Status: Recruiting
• Conditions: Spina Bifida or Spinal Dysraphism

Detailed Description

Spina bifida is a congenital defect of the spine where some of the spinal cord and its covering (meninges) are exposed through a gap in the lower back or sacrum; this often results in paralysis of the lower limbs. The majority of spina bifida (SB) patients also have pelvic floor dysfunction (bladder, bowel, prolapse, sexual function) because of neurologic damage to this portion of the spinal nerves, and this increases the risk of their long-term morbidity.1 These problems place a substantial burden on patients' physical health and quality of life (QoL). Serious urological complications, such as urosepsis, skin breakdown, and renal failure, can occur in this patient population due to bladder dysfunction.2 Approximately 50% of young adults with SB have renal dysfunction3, 50% have urinary incontinence4, and they are nine times more likely to present with urinary tract infections5. The "gold standard" bladder management strategy when a person with SB is unable to void spontaneously is to perform clean intermittent catheterization (CIC). Alternatives to CIC include spontaneous voiding (if possible), incontinence products, an indwelling catheter (IDC), or reconstructive surgery (to create a urinary diversion or to enable CIC). However, IDC and surgery have increased risks of specific complications, including the risk of bladder cancer, urethral damage, urinary infections, and surgical morbidity.6 People with SB usually discuss bladder management options with their urologist, however they may prioritize a variety of factors around bladder management that directly affect their QOL, and these may not be as apparent to urologists. This is further complicated when patients reach adolescence and young adulthood; at this age they transition from pediatric to adult care providers, all while transitioning in other areas of their life (such as increasing responsibility, cognitive growth, and a wish for more independence). These factors may all impact thoughts about bladder management. Few studies have addressed QoL in relation to different bladder/bowel management methods in this SB age group, and most have not considered things like health literacy and cognitive function.

1. Wiener JS, Suson KD, Castillo J, Routh JC, Tanaka ST, Liu T, Ward EA, Thibadeau JK, Joseph DB, Registry NSBP. Bladder Management and Continence Outcomes in Adults with Spina Bifida: Results from the National Spina Bifida Patient Registry, 2009 to 2015. The Journal of urology 2018;200:187-94.
2. Nooten FE van, Winnette R, Stein R, Kissner M, Schröder A, Jöckel M, Raluy-Callado M, Lambrelli D, Meinhardt M, Wasiak R. Resource utilization and productivity loss in persons with spina bifida-an observational study of patients in a tertiary urology clinic in Germany. European journal of neurology : the official journal of the European Federation of Neurological Societies 2015;22:53-8.
3. Malakounides G, Lee F, Murphy F, Boddy S-A. Single centre experience: long term outcomes in spina bifida patients. Journal of Pediatric Urology 2013;9:585-9.
4. Verhoef M, Lurvink M, Barf HA, Post MWM, Asbeck FWA van, Gooskens RHJM, Prevo AJH. High prevalence of incontinence among young adults with spina bifida: description, prediction and problem perception. Spinal Cord 2005;43:331-40.
5. Tradewell M, Pariser JJ, Nimeh T, Elliott SP, Group NBR. Systematic review and practice policy statements on urinary tract infection prevention in adults with spina bifida. Translational Andrology and Urology 2018;7:S205-19.
6. Snow-Lisy DC, Yerkes EB, Cheng EY. Update on Urological Management of Spina Bifida from Prenatal Diagnosis to Adulthood. The Journal of urology 2015;194:288-96.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Mary McKibbon, BNSc; Phone Number: 519-646-6367; Email: mary.mckibbon@sjhc.london.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • Recruiting
      • St Joseph's Hospital
      • Contact: Mary McKibbon, BNSc; Phone Number: 5196466367; Email: mary.mckibbon@sjhc.london.on.ca
      • Contact: Brenda Hodgins; Phone Number: 5196466000; Email: brenda.hodgins@sjhc.london.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

To be included in the study, participants had to be adolescents (13-17 years of age) or adults (≥18 years of age) with SB and no acute health changes. SB included all types, including SB occulta, meningocele, lipomeningocele, and myelomeningocele. We were interested in including the SB transitional age group as well, recognizing this age group represents unique and diverse psychosocial, cognitive and functional abilities.

Description

Inclusion Criteria:

1. Diagnosis of SB
2. Age ≥13 years of age
3. Able to effectively communicate in English or Spanish
4. Willing to provide informed consent for participation and answer a set of questionnaires

Exclusion Criteria:

1. Reconstructive surgery or urinary diversion in the last 3 months
2. Hospital admission in the last 1 month
3. Inconsistent or newly changed (within the last month) method of bladder management

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Voiding/incontinence; SB patients who manage their bladder with voiding/incontinence
CIC; SB patients who manage their bladder with clean intermittent catheters
Diversion; SB patients who manage their urination with a surgical bladder diversion
Indwelling catheter; SB patients who manage their bladder with an indwelling catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QUALAS bladder and bowel quality of life domain	The QUALAS is a validated quality of life measure for teens and adults with spina bifida. It is scored from 0-100, with a higher score meaning better QOL	At the time of enrollment

Collaborators and Investigators

• Sponsor: Blayne Welk
• Collaborators: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
• Investigators: Principal Investigator: Blayne Welk, MD MSc, Western University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; bladder; spina bifida; bowel
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Dysraphism
• Other Study ID Numbers: 15140 (City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will consider sharing data on a case by case basis, after the primary analysis is complete.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No